Agility Clinical is a small, but growing consulting and clinical research organization focused on conducting clinical trials for virtual, small biopharma and device companies, particularly those working on therapies for orphan diseases. We have a great working environment offering opportunities for advancement for individuals with the right skills, initiative and motivation. If you are customer service oriented and have a passion for making a difference, then Agility may be the place for you.

Biostatistician

We are seeing a highly-motivated Biostatistician to join Agility Clinical, Inc. This position provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs.

SCOPE AND RESPONSIBILITIES:

Generate randomization schedules.

Provide sample size calculations.

Provide input into development of case report forms (CRFs).

Author statistical analysis plans, including development of table and listing shells.

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

Perform quality control for SAS programs and other study documents (e.g., presentations and reports).

We are currently interviewing for a Clinical Data Coordinator for full time or part time positions at various levels. As a Clinical Data Coordinator, you will be responsible for assisting in managing one or more clinical trial databases for clinical trials, working with a variety of data management systems. As part of a project team, your areas of responsibility include assisting with CRF design, data management plans, database development, database quality control, medical coding, data review, clinical site training and database close activities.

DESIRED SKILLS & EXPERIENCE

Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required.

Management of all data-related tasks required to manage clinical data.

Responsible for the creation, updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data.

Key member of the clinical project team working directly with the clinical Project Manager and/or Director and should be able to prioritize work in line with project management decisions.

Work with the clinical Project Manager and/or Director to ensure oversight of the data management portion of the study budget, ensuring project remains within scope and that any out of scope activities are identified and handled as appropriate.

Clinical Research Associate/ Sr. CRA

We currently are interviewing for office and home (regional) based CRAs in all therapeutic areas to join our team. A broad range of CRA experience is highly desirable.

CRAs are responsible for monitoring the progress of clinical studies at investigative sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

SCOPE AND RESPONSIBILITIES

Independent and proactive coordination of all necessary activities required to set up and monitor a study (i.e., identify investigators; help prepare regulatory submissions, conduct pre-study and initiation visits, etc.).

Identify, select, initiate and close out appropriate investigational sites for clinical studies. You will monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with Agility SOPs, applicable regulations and the principles of ICH-GCP.

Approximately 50-70% travel overall can be expected, national and regional travel. The goal at Agility is to keep travel as regional as possible.

DESIRED SKILLS & EXPERIENCE

Undergraduate degree in a clinical, scientific, or related field, or equivalent work experience required (RN or LPN with at least 4 years of recent field monitoring experience).

Applicants must have at least 2 years of experience independently monitoring clinical trials for drug studies.

Drug Safety And Pharmacovigilance Professional

This is an exciting opportunity for a qualified individual interested in joining a growing safety surveillance and pharmacovigilance group that supports drug development for orphan and ultra‑orphan diseases and disorders. The title and level of responsibility will be commensurate with the candidate’s qualifications and previous experiences in safety and pharmacovigilance.

Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

In addition, the safety specialist/safety manager will contribute to; signal detection activities, the preparation of aggregate safety reports (DSUR, PADER, and PSUR) and the review of medical coding for consistency and medical accuracy.

Education Level and Requirements for the Position

Health care professional (nursing or pharmacy degree preferred)

Minimum of 3 years of clinical and/or study coordinator experience; industry experience in CRO or pharmaceutical company preferred

Manager, Biostatistics

This essential team member will be responsible for leading the biostatistics efforts for specific projects and studies, including reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. In addition, this team member will be responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Biostatistics team, this person will also provide technical expertise to the development of programming standards and procedures. Relocation assistance will be considered.

SCOPE AND RESPONSIBILITIES:

Manage employees within Biostatistics functional area.

Develop and maintain departmental procedures and standards.

Assist with project forecasting and resourcing needs through a combination of internal and external resources.

Hire, train, guide career growth, and provide development opportunities for Biostatisticians.

Provide oversight for assigned projects.

Provide technical oversight and leadership in the areas of analysis and reporting.

Generate randomization schedules.

Provide sample size calculations and assist in protocol development.

Provide input into development of case report forms (CRFs).

Author statistical analysis plans, including development of table and listing shells.

Review statistical analysis plans written by other Biostatisticians.

Write analysis plans for eCTD submissions (eg, ISS and ISE)

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

Perform quality control for SAS programs and other study documents (e.g., presentations and reports).

We are currently interviewing for experienced Clinical Data Management professionals for full time and part time positions at various levels. As a Manager, Data Management, you will be responsible for managing one or more direct reports in addition to managing one or more clinical trial databases for clinical trials, working with a variety of data management systems. As part of a project team, your areas of responsibility include management/supervision, CRF design, data management plans, database development, database quality control, medical coding, data management process and documentation development, data review, site training, database close and quality control audits. Potential for learning and participating in activities in other functional areas.

DESIRED SKILLS & EXPERIENCE

Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required.

Applicants must have at least 8-10 years of experience in a biopharmaceutical company or CRO.

We currently are interviewing for experienced office and home (regional) based managers. This team member will serve as the clinical team lead responsible for the planning, conduct and oversight of the operational portion of clinical studies, ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. This team member will also be responsible for managing one or more direct reports and providing oversight of training, performance and career management.

SCOPE AND RESPONSIBILITIES

Manage employees and/or contractors within the Clinical department.

Develop and maintain departmental procedures and standards.

Assist with project forecasting and resourcing needs through a combination of internal and external resources.

Hire, train, guide career growth, and provide development opportunities for Clinical employees.

Drive and manage the clinical and site management aspects of assigned studies.

Develop and maintain study plans, guidelines and tools.

Track and review monitoring reports.

DESIRED SKILLS & EXPERIENCE

Bachelor’s degree in a clinical, scientific, or related field, or equivalent work experience required

Applicants must have at least 8 years of experience in a biopharmaceutical company or CRO

Manager, Safety

Safety Managers are responsible for providing safety services for Agility clients including the development of project specific plans for the collection, triage, processing, and medical coding of adverse event (AE) data associated with clinical trials and/or post-marketing safety surveillance, and the management and development of safety staff.

This opportunity is based in our Carlsbad, CA office.

Essential duties:

Prepare and/or review project‑specific safety management plans

Provide safety services, including intake and triage of AEs, safety case processing, and writing comprehensive medical narratives and analyses of similar events (AOSEs) for expedited reporting

Manager, Statistical Programming

This essential team member will be responsible for leading the SAS statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. In addition, this team member will be responsible for managing resources within the Biostatistics and Statistical Programming department. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

Project Manager/ Sr. Project Manager

We currently are interviewing for Project Managers to join our team. The project manager plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

Assures that all aspects of project are performed in compliance with standard operating procedures (SOPs), client SOPs (if applicable), and International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines, and local laws where applicable.

Reviews and maintains project documents, files, and correspondence.

Assesses strengths and weaknesses of project at completion, and applies lessons learned to next project.

Assists Business Development group with contract/proposal preparation.

Assists in the formation of project teams for specific projects.

Assists in the performance review of project team members by reporting feedback to functional managers.

DESIRED SKILLS & EXPERIENCE

Bachelor’s degree in life sciences or related field and 6-8 years clinical research experience including 2-4 years of direct project management experience and experience in clinical operations; or equivalent combination of education, training and experience.

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

Good therapeutic and protocol knowledge

Strong communication and interpersonal skills, including good command of English language

Good problem solving skills

Demonstrated ability to deliver results to the appropriate quality and timeline metrics

Good teamwork skills

Excellent customer service skills

Good presentation skills

Good judgment

Strong software and computer skills, including MS Office applications

Ability to establish and maintain effective working relationships with coworkers, managers and clients

SAS Programmer

This essential team member will be responsible for supporting the SAS programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs.

SCOPE AND RESPONSIBILITIES:

Review CRFs, edit check specifications, and table mock-ups

Work with data management personnel on projects to identify database issues

Senior Biostatistician

We are seeing a highly-motivated Senior Biostatistician to join Agility Clinical, Inc. This position provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans, and developing SAS programs. This position reports to the Director of Biostatistics.

SCOPE AND RESPONSIBILITIES:

Generate randomization schedules.

Provide sample size calculations.

Provide input into development of case report forms (CRFs).

Author statistical analysis plans, including development of table and listing shells.

Review statistical analysis plans written by other Biostatisticians.

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

Perform quality control for SAS programs and other study documents (e.g., presentations and reports).

We are currently interviewing for an office based Senior Clinical Trial Associate. This position provides support to the Clinical Operations and Project Management department through the performance of project-specific tasks whereby contributing to the overall management of clinical trials. Will also provide a leadership and support to Clinical Trial Associates.

Essential Duties

Assist clinical study teams with all aspects of study management from study start-up to close-out on various studies simultaneously.

Assist with preparations of essential document templates, collection, and review. Perform study tracking to ensure that the study files are current, accurate and complete.

Create and maintain central study files for the duration of the study including assisting in file review and reconciliation for audits, in addition to preparing study files for archival.

Assist in planning, organizing and executing project-specific meetings including but not limited to Agility-Client meetings, CRA training meetings, and PI meetings.

May be responsible for non-drug supply tracking and shipping.

Process invoices and expense reports from regional CRAs which may include identification and resolution of questions to be brought to the Project Manager’s attention.

Lead team of Clinical Trial Associates (CTA) to ensure appropriate site management, essential document compliance, corporate metric review and study coding accuracy during start-up, maintenance and close out phases of study.

Take initiative to lead/support the project team to ensure successful activation of trials sites according to time, quality/scope and budget parameters.

Collaborate with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study.

Performs all duties in accordance with Agility Clinical’s SOPs, government regulations and Good Clinical Practices.

Knowledge, Skills and Abilities

High school diploma required, Associate Degree or equivalent college coursework in a related field of study preferred. Requires 1-2 years applicable experience, or equivalent combination of education an experience.

Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database.

Able to read an interpret documents such as safety rules, operating and maintenance instructions, an procedure manuals; to write routine reports an correspondence; to speak effectively before groups of customers or employees of organization.

Able to add, subtract, multiple, and divide in all units of measure, using whole numbers, common fractions, an decimals; to compute rate, ration an percent and to draw and interpret bar graphs.

Able to apply common sense understanding to carry out detailed but uninvolved written or oral instructions; to deal with problems involving a few concrete variables in standard situations.

Must possess a customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.

Senior Clinical Quality Assurance Associate

We’re looking for a Senior Clinical Quality Assurance Associate with clinical research and vendor audit experience to provide support in the implementation of our quality management system. Are you ready to be an integral part of a dynamic and growing clinical research organization in a company with diverse product offerings such as pharmaceutical, diagnostics and medical device?

About You:

You love traveling for business

You enjoy conducting a variety of vendor audits in both pharma and device trials

You love being in a consultative role where you can provide your GCP/ICH expertise to the team

You commonly focus on intricate details of a situation yet you are able to see the overall big picture

You enjoy establishing new groundwork in QA with risk based management strategies

You love being a mentor and a collaborator, sharing your knowledge to help grow and encourage peers and team members

Senior Director, Drug Safety & Pharmacovigilance

We are pleased to share this exciting opportunity for a Senior Director, Pharmacovigilance who is passionate about rare and orphan disease to join our growing business. As a member of our Senior Management team, you will have a blank slate when it comes to leading, developing and growing a new and innovative department.

Key safety services components focus will be on line management oversight, resourcing, business development, client project work and ARGUS.

About You:

You enjoy variety and knowing that no two days will ever be the same

You love seeing what you do every day impacts the lives of patients

You are a self-starter and enjoy taking calculated risks and pushing the boundaries of what others believe is possible

You are open-minded and always ask inquisitive questions that help you see things from various viewpoints and perspectives

Validated ability to challenge existing practices in order to become more effective.

Ability to effectively adapt to a variety of situations. Works while meeting quality and performance standards. Strong influencing skills, communication skills; both written and oral. Works effectively as a team member and promotes teamwork. Shown ownership, initiative and accountability

Sr. Director, Project Management

We currently are interviewing for a Sr. Director, Project Management to join lead our Project Management Department. The Sr. Director of Project Management plans, directs, coordinates, and delivers activities for designated clinical-study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Additionally, the Director will manage the team of associate directors, project managers and associate project managers.

SCOPE AND RESPONSIBILITIES:

Manage the department of project managers and associate project managers, including employees located in global offices worldwide.

Direct project forecasting and resourcing needs for the Project Management Department through a combination of internal and external resources.

Hire, train, guide career growth, and provide development opportunities for the Device and Diagnostic group.

Participates in Agility business development activities, including strategic input, leading capabilities and bid defense presentations. May travel to attend bid defense presentations and to meet with employees.

Work with business operations team to review/provide input to budgets and proposals for device and diagnostic business opportunities.

May attend trade shows or conferences

Responsible for the successful management of projects being conducted by Agility. Assigned to manage the full range of projects; from small limited scope projects to full service, large scale, complex programs.

Primary interface with Client representatives, as well as Agility personnel in applicable functional departments, to ensure the timely initiation and completion of clinical trials.

Coordinates initial client meeting identifying project objectives.

Identifies potential risks including bottlenecks/delays; develops and executes contingency plans in order to keep the project on schedule.

Interacts with applicable pharmaceutical, biotechnology clients, vendors, and Agility personnel to ensure that all contractual obligations are met.

Coordinates Project Team Meetings, including meeting facilitation and development of meeting agendas and minutes.

Coordinates study specific training and other requirements for internal and external staff, as appropriate.

Manages budget throughout the duration of the project and develops out of scope documentation and costs.

Bachelor’s degree in life sciences or related field and 10-15 years clinical research experience including 8 years of direct project management experience in and experience in clinical operations; or equivalent combination of education, training and experience. Prefer experience in leading and managing a department such as Project Management or Clinical Operations.

In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

Good therapeutic and protocol knowledge

Strong communication and interpersonal skills, including good command of English language

Good problem solving skills

Demonstrated ability to deliver results to the appropriate quality and timeline metrics

Good teamwork skills

Excellent customer service skills

Good presentation skills

Good judgment

Strong software and computer skills, including MS Office applications

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Senior Director Regulatory Affairs

We are currently seeking an experienced regulatory professional to oversee the Regulatory Affairs function in support of clients developing regulated products, for training of staff and for development of departmental processes in compliance with government regulations concerning investigational and approved products, ICH Guidelines, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs). This position involves strategic planning and communications with clients, regulatory authorities, and Agility personnel (employees and consultants).

SCOPE AND RESPONSIBILITIES:

Responsible for maintaining up-to-date knowledge of regulations, guidelines and pharmaceutical industry standards and practices with regard to regulated product development.

Ability to read, analyze, and interpret common scientific and technical journals, to respond to common inquires or complaints from regulatory agencies; to effectively present information to top management, public groups, and/or board of directors.

Able to define problems, collect data, establish facts, and draw valid conclusions; to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract an concrete variables.

Ability to evaluate regulations and electronic processes and requirements.

Must possess a professional demeanor, a customer service demeanor; demonstrate keen attention to detail, effective organization and time management skills, and the ability to communicate effectively.

Must possess the ability to multitask and manage multiple and changing priorities with adherence to deadlines.

Senior Statistical Programmer

This essential team member will be responsible for supporting the SAS statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project’s needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

SCOPE AND RESPONSIBILITIES:

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data

Generate SDTM domains, ADaM datasets, and Define.xml files

Perform quality control for SAS programs and other study documents (e.g., presentations and reports)

Document the quality control review process

Review output across programs to ensure consistency

Review, maintain, and approve study documents per standard procedures

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

Program, test, and document global utility programs and tools in accordance with standards and validation procedures

Provide technical oversight and leadership in the areas of analysis and reporting

Participate in the development and/or maintenance of departmental procedures and standards

Review CRFs, edit check specifications, and table mock-ups

Assist in creation of table mockups under supervision of statisticians

Serve as the primary project team representative, delegating work as appropriate

Train and mentor new programmers

DESIRED SKILLS & EXPERIENCE

BS degree in Statistics, Mathematics, or Computer Science or in a related field

Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer

Agility Clinical appreciates recruiter interest; however, unsolicited resumes or calls from third parties will not be accepted at this time. Agility does not accept unsolicited resumes from outside recruiting firms. Any resume submitted in the absence of a signed agreement will become the property of Agility and no fee shall be due.